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Model Number FA-77400-20
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Neurological Deficit/Dysfunction (1982); Seizures (2063); Therapeutic Response, Decreased (2271); Hydrocephalus (3272)
Event Date 07/28/2016
Event Type  Injury  
Manufacturer Narrative
Lang st, et al. J neurointervent surg 2017;9:e16. Doi:10. 1136/n eurintsurg- 2016-0 12506. Rep the pipeline embolization device (ped) performed as intended as indicated by successful implantation in the treatment of a blister a neurysm in the right supraclinoid ica. The ped remains implanted in the patient; product analysis cannot be performed. Based on the reported information, there does not appear to have been any defect of the device during use. The events occurred in the patient post-procedure and its cause could not be conclusively determined from the reported information. It should be noted that the ped was used in the treatment of a ruptured aneurysm, for which the device is contraindicated. Per the ped instructions for use, ¿pipeline¿ embolization device should not be used alone as sole therapy for acutely ruptured aneurysms. ¿ mdrs related to this article: 2029214-2017-01086 2029214-2017-01087.
Event Description
Medtronic literature review found a report that a patient experienced hydrocephalus as well as aneurysm recurrence after pipeline embolization device (ped) implantation. The patient had presented to the emergency department after a sudden collapse; the patient had a glasgow coma scale score of 3. Emergent ct/ct angiography demonstrated diffuse subarachnoid hemorrhage with a moderate amount of intraventricular blood. A small blister-type aneurysm was noted along the anterior aspect of the right supraclinoid internal carotid artery (ica), measuring 2 mm in diameter. After stabilizing, the patient was taken for a digital subtraction angiogram (dsa) with the intention to treat the aneurysm. Prior to the procedure, the patient was loaded with aspirin and clopidogrel. The angiogram revealed significant interval growth of the aneurysm, now measuring 7×6. 5×5 mm (fundus×height×neck). Two telescoping peds (4×16 mm and 4×20 mm) were positioned to cover the aneurysm neck. A final control angiogram demonstrated adequate coverage of the aneurysm neck. In the following days, the patient had several cta scans performed for assessment of vasospasm. On post treatment day 6, the aneurysm was not seen on cta. On post treatment day 12, an enlarging hyperdense focus in the right suprasellar cistern was found, consistent with a pseudoaneurysm. The next day, the patient was brought for a dsa with the intention to treat the lesion. However, this angiogram was discordant with the recent cta; the previously treated aneurysm in relation to the supraclinoid ica and related to the ped was seen, but was significantly smaller in size. There was no evidence of an enlarging pseudoaneurysm and no further treatment was undertaken. The patient subsequently had a protracted course in hospital due to the development of hydrocephalus requiring a ventriculoperitoneal shunt, and the onset of a seizure disorder, managed medically. The patient was eventually discharged and continued to recover in the community, with some residual cognitive deficit. Seven months post-treatment, cta was performed, which demonstrated successful treatment of the supraclinoid aneurysm, with no evidence of residual. Nine months post-treatment, a routine follow-up dsa demonstrated recurrence of the aneurysm, measuring 4. 5×4 mm, adjacent to the origin of the anterior choroidal and posterior communicating artery. The patient underwent placement of a third ped, which was performed without complication.
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Manufacturer (Section D)
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
9775 toledo way
irvine CA 92618
Manufacturer Contact
tricha miles
9775 toledo way
irvine, CA 92618
MDR Report Key6902864
MDR Text Key87727142
Report Number2029214-2017-01087
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 09/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberFA-77400-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/05/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/28/2017 Patient Sequence Number: 1